Ten-year outcomes after DES versus CABG for LM coronary disease: extended follow-up of the PRECOMBAT trial

Selected in Circulation by D. Milasinovic

This 10-year follow-up of the randomised PRECOMBAT trial adds to the already published long-term randomised comparisons of PCI vs. CABG for LM disease, including the data from SYNTAX (10 years), EXCEL (5 years) and NOBLE (5 years) trials.

Reviewer

Dejan Milasinovic

@MilasinD18

Interventional cardiologist / Cardiologist

Belgrade, Serbia

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My Comment

Why this study? – the rationale/objective

This is the 10-year follow-up of the randomised PRECOMBAT trial, which compared PCI vs. CABG for unprotected left main (LM) disease. Previously, no differences in terms of MACE and mortality were documented between the two strategies up to 5 years follow-up.

How was it executed? – the methodology

• 600 patients with LM disease (65% distal bifurcation) and mean SYNTAX score of 25 were randomised to PCI vs. CABG in 1:1 fashion.
• The primary outcome was the composite of death from any cause, nonfatal MI, nonfatal stroke, or ischemia-driven target vessel revascularisation.
• Median follow-up was 11.3 months (IQR 10.2-13.0). Vital status was available for all patients at 10 years.

What is the main result?

• There was no significant difference in terms of the primary outcome (29.8% in PCI vs. 24.7% in CABG, HR 1.25, 95% CI 0.93–1.69).
• The rates of all-cause death (14.5% in PCI vs. 13.8% in CABG) and death from cardiovascular causes (7.8% vs. 8.7%) were similar, as were the rates of MI and stroke.
• Target vessel revascularisation, as well as any repeat revascularisation was significantly more frequent in PCI-treated patients compared with CABG.

Critical reading and the relevance for clinical practice

This study adds to the already published long-term randomised comparisons of PCI vs. CABG for LM disease, including the data from SYNTAX (10 years), EXCEL (5 years) and NOBLE (5 years) trials.

At large, these trials seem to convey a similar set of messages. First, all-cause mortality appears to be similar in the long term, with the only exception being the EXCEL trial, while all trials (including EXCEL) showed no difference in terms of cardiac mortality. Second, CABG is consistently associated with a reduction in repeat revascularisations, which given recent data connecting repeat revascularisations with mortality, may impact clinical decision making. Third, the reported inconsistencies in the effect of CABG vs. PCI on the incidence of MI may largely be dependent on the trial’s MI definition. In this respect, the PRECOMBAT trial reported only 3.2% MI rate in the PCI group and 2.8% in the CABG group, during 10 years follow-up, which could be attributed to a restrictive MI definition (new Q-waves during hospitalisation, and clinically-driven spontaneous MI during later follow-up).

When interpreting the totality of evidence from these trials, at least the following two sets of potential effect modifiers may need to be kept in mind. First, the extent of the underlying coronary artery disease is of importance, as CABG seems to be associated with better results compared with PCI in cases of a more diffuse disease. Second, variations in the PCI arm such as the distal LM bifurcation stenting technique, use of intracoronary imaging and the operator’s LM PCI-specific expertise could have an impact on the overall results.

In summary, as interventionalists are gaining more widespread experience with LM PCI, careful patient (lesion) selection and standardised improvements in PCI technique remain paramount.

Updated pooled analysis of long-term all-cause mortality after PCI vs. CABG for left main disease

Updated pooled analysis of long-term all-cause mortality after PCI vs. CABG for left main disease